MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 11-nov-2022.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a 71-year-old male patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that a steam pop occurred during cti ablation and a pericardial effusion followed.There was an impedance spike and cut-off, the rf delivery automatically stopped on the smartablate generator at the time of the steam pop.The anesthesiologist notified the physician of a drop in the patient's blood pressure.The effusion was diagnosed using intracardiac echo, through "smokey" images.A pericardiocentesis was performed and a drain was placed and secured to leave in overnight.A transthoracic echo was performed during the pericardiocentesis.The patient's blood pressure stabilized, and they were transferred to the pacu for observation.The physician believed that biosense webster, inc.Products contributed to the patient event.Case type: afib/aflutter ablation.Additional information was received.The adverse event was discovered during use, or post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was the bwi product use during procedure.Interventions provided was a pericardiocentesis and cpr.Outcome of the adverse event was improved.The patient required extended hospitalization, because they left drain in after tap, so patient remains in intensive care unit for monitoring.Transseptal puncture was performed using a baylis versacross needle.Ablation was performed prior to noting the cardiac tamponade.There was evidence of a steam pop.The event occurred during the ablation phase.Standard flow rates for smart touch sf over 30w at 15ml/mi.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were graph, dashboard, vector, and visitag.Parameters for stability for the visitag module used were tag index with size 3mm lesions.There was no additional filter used with the visitag.Color options used prospectively was fti.The steam pop issue occurred during ablation of cti.Generator parameters was power control mode with impedance = 201; power = 40 w; temperature = unknown.The length (minutes and seconds) of the ablation cycle when the pop was observed at the same tip position was 19 seconds.

Manufacturer Narrative

Additional information was received on 21-nov-2022 stating the patient did not die and is fine.The device evaluation was completed on 22-nov-2022.It was reported that a 71-year-old male patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that a steam pop occurred during cti ablation and a pericardial effusion followed.There was an impedance spike and cut-off, the rf delivery automatically stopped on the smartablate generator at the time of the steam pop.The anesthesiologist notified the physician of a drop in the patient's blood pressure.The effusion was diagnosed using intracardiac echo, through "smokey" images.A pericardiocentesis was performed and a drain was placed and secured to leave in overnight.A transthoracic echo was performed during the pericardiocentesis.The patient's blood pressure stabilized, and they were transferred to the pacu for observation.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and impedance features were tested and no abnormalities were observed.In addition, the product was deflecting correctly and no blockages in the irrigation conducts were found; however, during the cool flow pump test, high-pressure values were observed due to the irrigation tube being bent in the shaft area.The root cause of this damage could not be conclusively determined; however, based on the information available, the device passed all the irrigation inspections during the manufacturing process.Therefore, this damage may have occurred during the handling of the device after the procedure outside the bwi manufacturing facilities.Subsequently, the force feature was tested, and force hi error and force vector inverted while on undeflected and deflected positions were displayed intermittently due to an internal printed circuit board (pcb) issue.No other malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The steam pop issue reported by the customer could not be replicated during the product investigation.The root cause of the adverse event remains unknown, force and irrigation issues regarding the product were found during this investigation but based on the event information they were unrelated to the event described.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿adverse event¿ and ¿steam pop¿ issues.-investigation findings: incompatible component/ accessory (c0402)/ investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the biosense webster¿s inc.Product analysis finding of the ¿pc board related¿ issue.-investigation findings: software problem identified (c10) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the biosense webster¿s inc.Product analysis finding of the ¿force hi error¿ and ¿force vector inverted¿ issues.-investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: circuit board (g02005) were selected as related to the biosense webster¿s inc.Product analysis finding of the ¿the irrigation tube being bent¿ issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15834318
• MDR Text Key: 304017178
• Report Number: 2029046-2022-02890
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30897956L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NON BWI- BAYLIS VERSACROSS NEEDLE; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male